SUPPLY CHAIN ARTICLES
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![coronavirus covid-GettyImages-1220020527]( "FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities")
FDA Sets Recommendations For Predicting Dangerous Nitrosamine ImpuritiesThe FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
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![Business Unity-GettyImages-1253212054]( "The RNA Therapeutics Supply Chain: A Platform of Relationships")
The RNA Therapeutics Supply Chain: A Platform of RelationshipsConversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.
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![Game Strategy-GettyImages-169983235]( "Inside Alnylam's Playbook For High Volume siRNA Production")
Inside Alnylam's Playbook For High Volume siRNA ProductionAs one of the first companies to establish a chemoenzymatic ligation platform, Alnylam's Maines and Nechev are in the perfect position to espouse wisdom on the practical aspects and remaining challenges of implementing enzymatic ligation at a large scale. Here in this installment, Maines and Nechev outline what they’ve learned thus far about the science of enzymatic ligation, while also paying credence to the unknowns and existing barriers that, as a frontrunner, Alnylam will inevitably (but willingly) be tasked with facing in the future.
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![Teamwok-GettyImages-1411776159]( "4 Risk Mitigation Strategies For mRNA Production")
4 Risk Mitigation Strategies For mRNA ProductionPlanning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.
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![GettyImages-1335381149]( "mRNA Vaccines: Key Considerations For Development & Manufacturing")
mRNA Vaccines: Key Considerations For Development & ManufacturingAs we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more.
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![Man working in vegetable garden-GettyImages-1327986655]( "Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions")
Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future DirectionsOverall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem.
SUPPLY CHAIN VIDEOS
Learn how single-use technologies deliver important benefits for mRNA manufacturing, including increased speed, quality, flexibility, and adaptability to different dosages and scale-up strategies.
What is the biggest hurdle to reaching metric-ton RNA production? In this segment, Advancing RNA Live speaker Claire McCleod discusses the biggest challenges to producing blockmers and in what ways the industry is reimagining upstream manufacturing to enable more efficient ligation.
The mRNA supply chain is undergoing massive growth in three particular areas. Here, speakers Khaled Yamout & Francoise Ribes walk us through the materials that have undergone the most scientific growth over the past few years and the impacts they’re noting these advancements having on the development of our mRNA drug substances and mRNA-LNP drug products.
Large scale production of plasmid DNA requires an in-depth understanding and optimization of the entire downstream process. Explore a complete solution, from harvest to bulk filtration.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1317697233-cancer-t-cells]( "A Novel RNA Lipid Nanoparticle Platform: Gene-Edited CAR T Cells For Off-The-Shelf Cancer Therapy")
We report on the use of a novel lipid nanoparticle (LNP) reagent in a validated protocol to achieve successful complex gene editing in primary T cells with high efficiency while maintaining high cell viability.
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![Scientist syringe vaccine GettyImages-1351831059]( "Overcome The Supply Chain Complexities Of Vaccine Development")
Explore the industry impact of rapidly evolving vaccinology, the power of next-gen science and technology, and how finding the right supply chain partner has never been more essential.
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![DNA molecules 450x300]( "Chromatographic Purification Of Plasmid DNA")
Widespread application of pDNA in gene therapy is driving increased demand and as a response, plasmid manufacturing must become more efficient with improved productivity. Intensification of chromatographic steps can help address this demand and has led to an exploration of the use of convective media (monoliths, membranes, fibre based technologies).
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![GettyImages-1418666846-scientist-lab-test-strip-vial]( "From LAL To rFC: The Evolution Of Endotoxin Testing")
Protect patient safety and ensure regulatory compliance by implementing sensitive, reliable bacterial endotoxin testing as a critical component of pharmaceutical quality assurance.
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![GettyImages-1333406903-liquid-nitrogen-cryopreservation-cold-chain]( "Accelerate Efficiency By Decoupling Collection From Manufacturing")
Cryopreservation eliminates rigid timelines by decoupling collection from production, providing the flexibility needed to optimize facility use and stabilize advanced therapy supply chains.
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![GettyImages-155372946-cold-chain-cryopreservation-logistics]( "Supercharge Your Supply Chain: Harness AI To Gain Competitive Advantage")
The success of CGTs hinges upon adherence to specific logistics protocols. Learn how the integration of AI in the pharma supply chain is poised to enhance visibility, efficiency, and compliance.
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![GettyImages-2183428951-biomanufacturing]( "The Evolution Of Nucleotide Production")
From harsh chemicals to gentle enzymes: Explore the groundbreaking shift in nucleotide synthesis, making drug manufacturing cleaner, greener, and more efficient.
